EU/3/02/088: Orphan designation for the treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis

Colistimethate sodium

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2011 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 19 February 2002, orphan designation (EU/3/02/088) was granted by the European Commission to Pharmax Limited, United Kingdom, for colistimethate sodium for the treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis.

Pharmax Limited changed its name to Forest Laboratories UK Ltd in July 2002.

Key facts

Active substance
Colistimethate sodium
Intended use
Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
Orphan designation status
Withdrawn
EU designation number
EU/3/02/088
Date of designation
19/02/2002
Sponsor
Forest Laboratories UK Ltd
Riverbridge House
Crossways Business Park
Dartford
Kent DA2 6SL
United Kingdom
Telephone: +44 1322 421800
Telefax: +44 1332 291306
E-mail: info@forest-labs.co.uk

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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